This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).

Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization

Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed

Other Names:

OptiVol

CareLink

Medtronic Concerto

Medtronic Consulta

Medtronic Secura

Medtronic Virtuoso

No Intervention: 2

No Care Alerts available, standard treatment of the patient

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device

Patient consents to study

Ability to replace follow-ups with CareLink follow-ups

Ability to attend all follow-ups at study center

Exclusion Criteria:

Permanent AF

Less than 18 years of age

Life expectancy less than 15 months

Participation in another clinical study

Pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730548